At Alera Labs, we are dedicated to providing exceptional analytical services that meet the distinctive needs of the Biotechnology industry. Our extensive expertise enables us to develop and validate a wide array of analytical assays for various drug substances and products, ensuring quality control and regulatory compliance. We conduct forced degradation studies and develop stability indicating assays to assess the stability of drugs and identify degradation products. Our stability testing services evaluate the shelf-life and integrity of biotechnology products, providing vital data for regulatory submissions. In compliance with ISO10993 guidelines, we perform extractables and leachables studies to assess the potential migration of substances from medical devices or packaging materials, guaranteeing biocompatibility and safety. We optimize, troubleshoot, and facilitate the transfer of analytical methods, ensuring robust and reliable analysis for our biotechnology clients. Our comprehensive services for the development, validation, and sample analysis of dose verification tests ensure accurate measurement in GLP toxicology studies. We excel in the development and validation of bioassays for pharmacokinetics studies, providing invaluable insights into drug absorption, distribution, metabolism, and excretion. Utilizing advanced techniques, we elucidate chemical structures and identify impurities, bolstering the characterization and quality control of biotechnology products. Additionally, we provide formulation development services, tailoring formulations for various drug products to optimize drug delivery, stability, and efficacy. Trust Alera Labs to deliver industry-leading analytical services that drive innovation, safety, and success in the Biotechnology industry.
1. Development and validation of wide spectrum of analytical assays for various drug substances and drug products
Techniques used: HPLC, LC-MS, LC-MS/MS
Alera Labs specializes in developing and validating a wide range of analytical assays to support the biotechnology industry in the analysis of drug substances and products, ensuring quality and regulatory compliance.
Alera Labs, a nimble analytical chemistry service provider located in North Carolina, offers specialized development and validation of diverse analytical assays for the biotechnology industry. With a focus on quality and regulatory compliance, the lab excels in aiding the analysis of various drug substances and products.
Utilizing advanced techniques such as High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), the team at Alera Labs ensures reliable and accurate results. Whether it’s a biotech start-up investigating a new therapeutic molecule or a well-established firm needing detailed analysis of an innovative drug product, Alera Labs provides services tailored to meet specific client needs.
The spectrum of services includes, but is not limited to, purity analysis, assay development, stability studies, and moisture content determination. Alera Labs’ reputation as a proficient and dedicated HPLC and LC-MS laboratory ensures its clientele of the superior quality of its analytical services.
At Alera Labs, the priority lies in top-quality science and excellent customer service, allowing the company to provide timely and cost-effective solutions to the biotechnology industry, regardless of the project’s size.
2. Forced degradation studies and stability indicating assays development
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
The team conducts studies to simulate degradation processes and develop stability indicating assays, enabling the assessment of drug stability and the identification of degradation products.
Alera Labs, a renowned analytical chemistry service provider in North Carolina, offers specialized services to the biotechnology industry, including forced degradation studies and the development of stability indicating assays. These studies play a crucial role in assessing the stability and integrity of drug substances and products.
Utilizing cutting-edge techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry(GC-MS), and Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), the team at Alera Labs conducts in-depth investigations to simulate degradation processes and identify degradation products. This allows for a comprehensive evaluation of drug stability over time.
Forced degradation studies involve subjecting drug substances or products to various stress conditions such as heat, light, pH changes, and oxidation. By analyzing the resulting degradation products using advanced chromatographic and mass spectrometric techniques, Alera Labs can provide valuable insights into the stability and degradation pathways of biotechnological products.
The development of stability indicating assays is equally important. These assays are designed to detect and quantify specific degradation products or impurities that can potentially form during the shelf-life of a drug product. By validating these assays, Alera Labs ensures their accuracy and reliability in assessing the stability of biotechnological products.
Researchers in North Carolina seeking expertise in forced degradation studies and stability indicating assays can rely on Alera Labs’ extensive experience and advanced analytical capabilities. The company’s adherence to regulatory guidelines and customer-centric approach make them a trusted partner for biotechnology companies in North Carolina and beyond.
3. Stability testing
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
Alera Labs’ stability testing services help evaluate the shelf-life and integrity of biotechnology products, providing crucial data for regulatory submissions and ensuring product quality and efficacy.
Alera Labs, a contact research service provider in the biotechnology industry, offers comprehensive stability testing services to assess the shelf-life and integrity of biotechnology products. With a focus on utilizing advanced techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), Alera Labs ensures accurate and reliable stability testing.
Stability testing is a vital component of product development and regulatory submissions in the biotechnology industry. It involves subjecting products to various environmental conditions, such as temperature, humidity, and light, to simulate their expected storage and usage conditions. By monitoring the product over time using sophisticated analytical techniques, Alera Labs can evaluate its stability, degradation patterns, and potential changes in quality attributes.
The utilization of HPLC, GC-MS, LC-MS, and LC-MS/MS in stability testing allows for the detection and quantification of degradation products, impurities, and other critical parameters. These techniques provide valuable insights into the product’s chemical composition, purity, and overall quality. By assessing the stability of biotechnology products, Alera Labs helps ensure their efficacy, safety, and compliance with regulatory requirements.
Researchers and companies in the biotechnology industry can rely on Alera Labs’ stability testing services to generate crucial data for regulatory submissions and quality assurance. The company’s expertise in utilizing advanced analytical techniques, combined with the commitment to delivering accurate and reliable results, makes us a trusted partner in ensuring the stability and quality of biotechnology products.
4. Extractables and leachables studies following ISO10993, Biocompatibility studies
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS,
Following ISO10993 guidelines, Alera Labs performs studies to assess the potential migration of substances from medical devices or packaging materials, ensuring biocompatibility and safety.
Alera Labs, as a provider of analytical chemistry services in the biotechnology industry, specializes in conducting extractables and leachables studies following ISO10993 guidelines. These studies are essential for assessing the potential migration of substances from medical devices or packaging materials and ensuring biocompatibility and safety.
Extractables and leachables studies play a crucial role in the evaluation of medical devices and packaging materials intended for use in biotechnology applications. These studies aim to identify and quantify the extractable and leachable compounds that may come into contact with biological systems. Alera Labs utilizes a range of advanced analytical techniques, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS)to analyze and characterize these compounds.
By following ISO10993 guidelines, Alera Labs ensures that the extractables and leachables studies are conducted in a standardized and comprehensive manner. This helps in the identification of potential risks associated with the migration of substances and supports the development of biocompatible medical devices and safe packaging materials.
The use of HPLC, GC-MS, LC-MS, and LC-MS/MSin extractables and leachables studies enables the detection, identification, and quantification of a wide range of compounds. These techniques provide valuable information about the chemical composition and potential toxicological effects of the substances that could leach from the materials. Alera Labs’ expertise in utilizing these advanced analytical techniques ensures accurate and reliable results for biotechnology companies seeking to assess the biocompatibility and safety of their products.
Researchers and companies in the biotechnology industry can trust Alera Labs’ extractables and leachables studies to meet regulatory requirements and provide comprehensive insights into the potential risks associated with medical devices and packaging materials. Alera Labs’ commitment to high-quality analytical chemistry services, adherence to ISO10993 guidelines, and utilization of advanced techniques make them a trusted partner in ensuring biocompatibility and safety in the biotechnology field.
5. Method optimization, troubleshooting, and transfer
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
The company optimizes, troubleshoots, and facilitates the transfer of analytical methods, ensuring robust and reliable analysis for biotechnology companies.
Alera Labs, a reputable provider of analytical chemistry services in the biotechnology industry, specializes in method optimization, troubleshooting, and transfer. Our expertise in this area ensures robust and reliable analysis for biotechnology companies.
Method optimization is a critical step in analytical chemistry, as it aims to improve the performance, efficiency, and reliability of analytical methods. Alera Labs utilizes advanced techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) to optimize analytical methods specific to the biotechnology industry. By fine-tuning parameters, adjusting instrument settings, and optimizing sample preparation techniques, we enhance the accuracy, sensitivity, and selectivity of the methods, leading to more reliable and precise results.
Troubleshooting is another key aspect of our services. Alera Labs’ experienced team of analytical chemists excels in identifying and resolving issues that may arise during method execution. Whether it involves unexpected peaks, poor reproducibility, or other challenges, we employ systematic troubleshooting techniques to diagnose and rectify the problems. Our goal is to ensure the consistent and accurate performance of analytical methods, minimizing potential errors and uncertainties.
In addition to optimization and troubleshooting, Alera Labs also offers method transfer services. Method transfer involves the successful transition of an analytical method from one laboratory or site to another while maintaining its accuracy and reliability. Our team is well-versed in the complexities of method transfer, including the alignment of instrument configurations, standardization of procedures, and comprehensive documentation. Through effective communication and collaboration, we facilitate a seamless transfer process, ensuring that the analytical methods perform consistently across different laboratory environments.
By utilizing HPLC, GC-MS, LC-MS, and LC-MS/MS techniques, Alera Labs delivers comprehensive method optimization, troubleshooting, and transfer services tailored to the specific needs of the biotechnology industry. Our commitment to robust and reliable analysis helps biotechnology companies streamline their analytical processes, improve data quality, and meet regulatory requirements.
Biotechnology researchers and companies can rely on Alera Labs’ expertise and dedication to deliver top-quality analytical chemistry services. Our method optimization, troubleshooting, and transfer capabilities contribute to the success of biotechnology projects by ensuring accurate and reliable analysis throughout the research, development, and quality control processes.
6. Development, validation, and sample analysis for dose verification testing for GLP toxicology studies
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
Alera Labs offers comprehensive services for the development, validation, and sample analysis of dose verification tests, ensuring accurate measurement of drug doses in GLP toxicology studies.
Alera Labs, a trusted provider of analytical chemistry services in the biotechnology industry, offers comprehensive solutions for the development, validation, and sample analysis of dose verification tests. Our expertise in this area ensures accurate measurement of drug doses in Good Laboratory Practice (GLP) toxicology studies.
Dose verification testing is a critical component of GLP toxicology studies, as it involves determining the precise amount of a drug or compound administered to test subjects. Alera Labs specializes in the development of dose verification methods tailored to the specific requirements of biotechnology companies. Our experienced team of analytical chemists works closely with clients to design and optimize dose verification protocols, ensuring accurate and reliable measurements.
The validation of dose verification methods is an essential step in ensuring the accuracy, precision, and robustness of the analytical procedures. Alera Labs follows rigorous validation protocols to assess the performance characteristics of the developed methods. Through method validation studies, we evaluate parameters such as linearity, accuracy, precision, specificity, and sensitivity to demonstrate the reliability and suitability of the dose verification methods for GLP toxicology studies.
Sample analysis forms a significant part of our services, as it involves the actual measurement of drug doses in the samples obtained from GLP toxicology studies. Alera Labs utilizes a range of advanced techniques, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), to analyze the samples and determine the accurate drug concentrations. Our state-of-the-art instruments, coupled with our expertise in method development and validation, ensure precise and reliable sample analysis results.
By employing HPLC, GC-MS, LC-MS, and LC-MS/MS techniques, Alera Labs delivers comprehensive development, validation, and sample analysis services for dose verification testing in GLP toxicology studies. Our commitment to accuracy, precision, and regulatory compliance enables biotechnology companies to confidently measure and validate drug doses, ensuring the integrity and reliability of their toxicological studies.
Biotechnology researchers and companies can trust Alera Labs to provide expert support in the development, validation, and sample analysis of dose verification tests. With our focus on accuracy, reliability, and adherence to GLP guidelines, we contribute to the successful execution of toxicology studies, providing crucial data for assessing the safety and efficacy of biotechnology products.
7. Development and validation of bioassays for pharmacokinetics studies
Techniques used: HPLC, LC-MS, LC-MS/MS
The team’s expertise includes the development and validation of bioassays to study drug pharmacokinetics, providing valuable insights into drug absorption, distribution, metabolism, and excretion.
In the biotechnology industry, Alera Labs specializes in the development and validation of bioassays tailored for pharmacokinetics studies. Our team’s expertise lies in designing and validating these bioassays, which play a crucial role in understanding the absorption, distribution, metabolism, and excretion (ADME) of drugs.
Pharmacokinetics studies are essential in evaluating how drugs are processed within the body, including their absorption into the bloodstream, distribution to tissues, metabolism, and eventual elimination. By utilizing advanced techniques such as High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), Alera Labs enables accurate and sensitive analysis of drug compounds and their metabolites.
The development of bioassays for pharmacokinetics studies involves creating experimental models or systems to mimic biological processes and assess drug behavior. Alera Labs works closely with biotechnology companies to customize bioassays according to their specific drug compounds and study objectives. We meticulously optimize and validate these bioassays, ensuring their reliability, sensitivity, and specificity.
Our experienced team of scientists employs HPLC, LC-MS, and LC-MS/MS techniques to detect and quantify drug compounds and their metabolites in biological samples. These analytical techniques enable the precise measurement of drug concentrations, even at low levels, and provide valuable insights into pharmacokinetic properties.
The validation of bioassays is a critical step in ensuring their accuracy and reproducibility. Alera Labs follows rigorous validation protocols, including assessing parameters such as linearity, accuracy, precision, selectivity, and robustness. Through thorough validation, we provide confidence in the performance of the bioassays, ensuring the reliability of the pharmacokinetics data generated.
By leveraging HPLC, LC-MS, and LC-MS/MS techniques, Alera Labs supports the biotechnology industry by offering expert development and validation of bioassays for pharmacokinetics studies. Our focus on precision, sensitivity, and regulatory compliance enables biotechnology companies to obtain valuable insights into the ADME of their drug compounds.
Researchers and companies in the biotechnology industry can rely on Alera Labs’ specialized expertise and advanced analytical capabilities to develop and validate bioassays for pharmacokinetics studies. With our commitment to scientific excellence and accurate data generation, we contribute to the understanding of drug behavior within the body, supporting the advancement of biotechnology products and therapies.
8. Structure elucidation and Impurity Identification
Techniques used: HPLC, LC-MS, LC-MS/MS, FT-IR, GC-MS, 1D and 2D NMR
Alera Labs utilizes advanced techniques to elucidate chemical structures and identify impurities, supporting the characterization and quality control of biotechnology products.
In the biotechnology industry, Alera Labs specializes in structure elucidation and impurity identification, employing a wide range of advanced analytical techniques. Our expertise in these areas contributes to the characterization and quality control of biotechnology products, ensuring their safety, efficacy, and regulatory compliance.
Structure elucidation is a crucial process that involves determining the chemical structure of a compound or molecule. Alera Labs utilizes various analytical techniques, including High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), LC-MS/MS, Fourier Transform Infrared Spectroscopy (FT-IR), and Gas Chromatography-Mass Spectrometry (GC-MS), 1D and 2 D Nuclear Magnetic Resonance (NMR) to elucidate the structures of complex molecules and compounds found in biotechnology products.
Our team of experienced scientists and analysts meticulously analyzes samples using these advanced techniques, allowing us to identify and confirm the chemical structures of the components present. By elucidating the structures, we gain insights into the composition, purity, and stability of biotechnology products, ensuring their quality and integrity.
Impurity identification is another critical aspect of quality control in the biotechnology industry. Alera Labs utilizes HPLC, LC-MS, LC-MS/MS, FT-IR, GC-MS, and NMR techniques to detect, identify, and quantify impurities in biotechnology products. Impurities can arise from various sources such as raw materials, synthesis processes, or storage conditions. It is essential to identify and quantify these impurities accurately to ensure product safety and compliance with regulatory requirements.
Our advanced analytical techniques allow us to separate, detect, and analyze impurities present in biotechnology products. By comparing the obtained data with reference standards and databases, we can accurately identify impurities and determine their levels or concentrations. This information is vital for assessing the quality, purity, and safety of biotechnology products and ensuring compliance with regulatory guidelines.
At Alera Labs, we prioritize the use of HPLC, LC-MS, LC-MS/MS, FT-IR, GC-MS, and NMRtechniques to perform structure elucidation and impurity identification. These techniques provide us with the highest level of sensitivity, specificity, and accuracy in our analyses, enabling us to support the biotechnology industry in their quality control efforts.
Researchers and companies in the biotechnology industry can rely on Alera Labs’ specialized expertise and advanced analytical capabilities for structure elucidation and impurity identification. By employing state-of-the-art techniques and rigorous analytical protocols, we assist in the characterization, quality control, and regulatory compliance of biotechnology products, ensuring their safety and efficacy in various applications and therapies.
9. Formulation development for various drug products (tablets, gels, etc.)
Techniques used: HPLC, GC-MS, LC-MS, LC-MS/MS
The company provides formulation development services for various drug products, including tablets, gels, and more, tailoring formulations to optimize drug delivery, stability, and efficacy in the biotechnology industry.
Alera Labs, a provider of analytical chemistry services in the biotechnology industry, offers specialized formulation development services for a wide range of drug products. With our expertise and advanced techniques, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), we excel in formulating pharmaceutical products such as tablets, gels, and other dosage forms.
Formulation development is a crucial step in the biotechnology industry as it focuses on optimizing drug delivery, stability, and efficacy. Alera Labs understands the unique requirements of each drug product and employs a systematic approach to tailor formulations that meet specific needs and objectives.
Using our HPLC, GC-MS, LC-MS, and LC-MS/MS techniques, we analyze and assess the compatibility and interactions between drug substances, excipients, and other formulation components. This enables us to optimize the formulation composition, ensuring the drug’s stability, solubility, and bioavailability.
Our experienced team of scientists and formulation experts works closely with clients to understand their specific requirements, including targeted drug release, dosage form characteristics, and patient compliance. We leverage our extensive knowledge and technical capabilities to develop formulations that meet these requirements and provide enhanced therapeutic outcomes.
Throughout the formulation development process, we employ rigorous quality control measures and analytical testing using HPLC, GC-MS, LC-MS, and LC-MS/MS techniques. These techniques enable us to assess the integrity, purity, and performance of the formulated products, ensuring they meet the necessary standards for safety, efficacy, and regulatory compliance.
At Alera Labs, we strive to optimize the formulation development process for our clients in the biotechnology industry. By utilizing HPLC, GC-MS, LC-MS, and LC-MS/MS techniques, we offer comprehensive analytical support and scientific expertise to create innovative and effective drug formulations. Whether it’s tablets, gels, or other drug products, our tailored formulations aim to improve drug delivery, stability, and overall therapeutic efficacy in the field of biotechnology.
Alera Lab caters to the broader life sciences industry, which encompasses various sectors such as biotechnology, genetics, and medical devices. We provide analytical laboratory services for research, analysis, and quality control purposes. This may include genetic analysis, testing of medical devices and materials, analysis of biotechnology products, and general analytical chemistry services tailored to the specific needs of the life sciences industry.